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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm January 02, 2018
Date Posted May 04, 2018
Recall Status1 Terminated 3 on February 10, 2023
Recall Number Z-1689-2018
Recall Event ID 79505
510(K)Number K010050  
Product Classification Acid, folic, radioimmunoassay - Product Code CGN
Product ADVIA Centaur¿ Folate (FOL)
Code Information ADVIA Centaur¿ Folate; acid, folic, radioimmunoassay; SMN 10310308; 10325366; 10331250   Lot codes: ADVIA Centaur Folate (REF) Lot # 03460256 09302256 81236256 09294257 30152258 ADVIA Centaur Folate (100 Test) Lot # 76793256 85114256 96368256 05299257 99361257 19045258 25443258 40856260 ADVIA Centaur Folate (500 test) Lot # 73249256 76207256 85113256 00245257 00495257 03779257 05298257 99360257 19042258 19043258 19044258 31130258 36171260 
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information Contact Ms. Aarti M. Aziz
914-631-8000
Manufacturer Reason
for Recall		 Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.
FDA Determined
Cause 2		 Error in labeling
Action Siemens Healthcare Diagnostics issued a recall in March 2017 for products with incorrect units for biotin in the Instructions for Use. After further investigation, recalling firm determined that more Siemens products also had missing or incorrect information in the IFUs for which two recalls were initiated, and Amended Corrections and Removals Reports were submitted to the FDA
Distribution Nationwide and Canada, Mexico, and Thailand
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CGN and Original Applicant = BAYER DIAGNOSTICS CORP.
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